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Small and Mid size Biotech Companies’ EDMS

Pocket EDMS URS include now TMF requirements

Pocket EDMS is a reference EDM implementation protocol for small sized companies. Pocket EDMS is based on a Universal Requirements Specifications set including, Users, System and Quality/Regulatory Requirements. It also includes a Q&A document (replacing the traditional RFI – Request for Information) and a set of notation tools allowing sponsor companies to easily evaluate vendor proposals.

In order to qualify for Pocket EDMS implementation, a package must provide capacity for Electronic Document Management including Quality documentation and Electronic Trial Master Files, with extensions to Publishing / ECTD and Regulatory Information Management. It must be priced according to the limited needs of small companies and be based on existing standards (EDM Reference Model, GMP Quality Systems Reference Model, TMF Reference Model…) as described in the Pocket EDMS specifications.

The Pocket EDMS Requirements Specifications are the result of collaboration from a large number of contributors. They are aimed at streamlining the implementation process by removing all the steps that do not constitute a field of differentiation between software packages. Thus, competition is limited to price and services offered by the participant vendors.